VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]

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VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH (PRAMOXINE HYDROCHLORIDE) CLOTH [COMBE INCORPORATED]
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NDC 11509-5035-1, 11509-5058-1
Set ID b848f53d-8aea-4efe-aa2c-009d5121fc33
Category HUMAN OTC DRUG LABEL
Packager Combe Incorporated
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    VAGISIL Anti-Itch Medicated Wipes

    Drug Facts

  • Active ingredient

    Pramoxine Hydrochloride 1% (w/w)

  • Purpose

    External analgesic

  • Use

    Temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

  • Stop use and ask doctor if

    condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children
    12 years and older          

                         		Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.
    children under 12 yearsconsult a doctor
  • Inactive ingredients

    water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

  • SPL UNCLASSIFIED SECTION

    VAGISIL Anti-Itch Medicated Wipes

    Drug Facts

  • Active ingredient

    Pramoxine Hydrochloride 1% (w/w)

  • Purpose

    External analgesic

  • Use

    Temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

  • Stop use and ask doctor if

    condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children
    12 years and older          

    		Unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.
    children under 12 yearsconsult a doctor
  • Other information

    Store at room temperature

    Discard within 2 months of opening

  • Inactive ingredients

    water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

  • Principal Display Panel

    Maximum Strength
    Vagisil    ®

    Anti-Itch Medicated Wipes

    Instant Relief From Intense Itch

    Gynocologist Tested

    Clinically Tested

    Triple-Action Itch Relief

    Wipes Away Intense Itch On Contact

    Soothes and Cleanses Skin

    Patented Odor Block Technology

    12 individually wrapped disposable wipes

    5 in. x 7.28 in. (12.7 cm x 18.5 cm)

    Maximum Strength Vagisil® Anti-Itch Medicated Wipes Instant Relief From Intense Itch Gynocologist Tested Clinically Tested Triple-Action Itch Relief Wipes Away Intense Itch On Contact Soothes and Cleanses Skin Patented Odor Block Technology 12 individually wrapped disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)

  • Principal Display Panel

    Vagisil®
    Maximum Strength

    Anti-Itch Medicated Wipes

    Clinically Tested

    Instant Relief From Intense Itch

    Triple-Action Relief

    Wipes Away Intense Itch On Contact
    20 soft, disposable wipes

    5 in. x 7.28 in. (12.7 cm x 18.5 cm)

    Vagisil® Maximum Strength Anti-Itch Medicated Wipes Clinically Tested Instant Relief From Intense Itch Triple-Action Relief Wipes Away Intense Itch On Contact 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)

  • INGREDIENTS AND APPEARANCE
    VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    TRIETHANOLAMINE COCOYL GLUTAMATE (UNII: LA19WH54UL)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11509-5035-112 in 1 CARTON06/28/2005
    14.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34706/28/2005
    VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    TRIETHANOLAMINE COCOYL GLUTAMATE (UNII: LA19WH54UL)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11509-5058-120 in 1 POUCH06/28/2005
    13.4 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34706/28/2005
    Labeler - Combe Incorporated (002406502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Combe Laboratories, Inc.808100197MANUFACTURE(11509-5035, 11509-5058)
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